Apparatus for separating and injecting blood component

ABSTRACT

The device comprises a system of blood-taking and decanting pockets interconnected by tubes, a storage pocket, the dimensions of which correspond to the amount of component to be injected, a filter and injection means in this storage pocket. The device is particularly useful for separating by cryo-precipitation and for injecting into a patient the factor VIII used against haemophilia.

United States Patent 1191 Viguier 1 1 Mar. 11, 1975 APPARATUS FORSEPARATING AND 2,842,122 7/1958 Butler 128/214 D IN BL 0D COMPONENT2,848.995 8/1958 Ryannnm 128/214 D INJECT G 0 3,064,647 11/1962 Earl128/272 x [75] Inventor: Leon Fernand Viguier, Samt-Prerre 3,110,30811/1963 Bellamy, Jr 128/214 D de Mesage, France 3,187,750 6/1965Tenczar, Jr. 1 128/272 3, 4 9 3 2 K l2 4 D [73] Assignee: LaboratoriesMedicoplast, Paris 6 8 6 3 Oremura (Seine), France [22] Filed: Oct. 6,1972 Primary E.t arninerAldrich F. Medbery [21] Appl. No.: 295,687

57 ABSTRACT [30] Foreign Application Priority Data 1 OCT. l3, FI'ZIHCCTh device omprises a ystem of blood taking and decanting pocketsinterconnected by tubes, a storage U-S- r D, pocket the dimensions ofcorrespond to [he [5 e amount f component to be injected a filter and inl l Field of Search l28/2l4 R1214 D1214 E, jection means in this storagepocket. The device is 128/272 214-2 particularly useful for separatingby cryo-precipitation and for injecting into a patient the factor VIIIused l l Referne$ Clted against haemophilia.

UNITED STATES PATENTS 2 2,702,034 2/1955 Walter 128/272 X 5 Claims, 3Drawing Figures RHENIED NARI 1 I915 SHEET 1 0F 3 WNX FATEMEU 1 SWEET 2OF 3 I 1 APPARATUS FOR SEPARATING AND INJECTING BLOOD COMPONENT vein andis stored in a first blood-taking pocket, where it undergoes a firsttreatment for initial separation. One of the components is thentransferred to a second pocket in the system for a second separationtreatment. One of the elements separated after this second treatment ispassed to a final pocket where it is stored.

The element thus separated and intended to be injected into a patient istaken from this storage pocket by means of a hollow needle which is usedto pierce the pocket. In the case of a blood component containingagglomerated elements, however, the device just described hasdisadvantages, since the agglomerated particles may obstruct the passagein the hollow needle or may enter the patients vein and createcirculation problems. Incidents of this kind generally occur where theblood component has been separated by cryoprecipitation, sinceagglomerated elements still remain after thawing. In order to avoid suchincidents, it is usual to dilute the component in a solution, especiallyan isotonic solution, before injecting it into the patient. Thisoperation is usually carried out in an adjacent pocket into which theconstituent taken is introduced by means of the hollow needle.

For the purpose of overcoming these disadvantages, it is also known tofilter the blood before injecting it ,into the patient. A transfusiondevice of this kind is described in US. Pat. No. 2,702,034 filed on July20, 1950. The filter chamber, usually of large capacity, is integratedinto the means of transfusion and the dead volume of the lattertherefore makes it impossible to use it for injecting small quantities.

Finally it is very difficult to remove the liquid from the storagepocket in a perfectly sterile manner in order to dilute it in theisotonic solution and inject it, while eliminating any riskofcontamination of the element to be injected.

It is an object of this invention to provide a method and an apparatusto overcome these disadvantages and difficulties. The method inaccordance with the present invention consists in the following steps:

the component is transferred in a sterile manner to a storage pocketconnected to the system of blood-taking and decanting pockets, thepocket comprising an internal filter and having dimensions correspondingto the amount of component isolated;

the storage pocket is separated from the system of blood-taking anddecanting pockets, and

the component is kept in the storage pocket until it is injected intothe patients vein.

According to one embodiment of the invention, before the component justisolated is transferred to the storage pocket, it is mixed with arinsing solution, especially an isotonic solution, which dilutes, inpart, the agglomerated elements; this rinsing solution is contained in apocket connected in a sealed and sterile manner to the system ofblood-taking and decanting pockets.

The apparatus made in accordance with the present invention consists ofa storage pocket containing a filter and having dimensions correspondingto the quantity of component isolated. The arrangement of the filterwithin the storage pocket is essential, since it produces adevice whichis particularly compact and easy to use, in which dead volumes aregreatly limited. This is essential if the quantities of componentextracted from the blood are very small.

According to another embodiment of the invention, the storage pocketalso comprises injection means adapted to the end of the filter. Thepurpose of this arrangement is to avoid contamination of the componentsin the storage pocket at the time of their injection, but this highlycompact arrangement of the injection means also helps to greatly limitdead volumes.

According to another embodiment of the apparatus of the invention, theisotonic solution is kept, prior to use, in the storage pocket. Thus thestorage pocket, which comprises a filter and injection means, contains asolution of the blood component already diluted and ready to beinjected.

The invention will now be described in greater detail in conjunctionwith two forms of embodiment given by way of examples only, andillustrated in the attached drawings, wherein:

FIG. 1 shows a side elevational view of the device according to theinvention;

FIG. 2 shows a side elevational view of the storage pocket, partlybroken away and to an enlarged scale; and

FIG. 3 shows a side elevational view of another embodiment of the deviceaccording to the invention.

Illustrated in FIG. I is a device which comprises a first flexiblepocket 1 made of transparent synthetic material. Opening into thispocket is the end of a flexible tube 3 made of weldable syntheticmaterial, the other end thereof being integral with a hollow needle 4protected by a sleeve 5.

Opening into pocket 1 is one end of a tube 8 made of weldable syntheticmaterial, the other end of which is integral with one arm of a three-wayunion 9, the other two arms of which are connected respectively, throughtubes 11 and 12, to flexible pockets 6 and 10. Pocket 10 is connectedthrough a tube 13 to a storage pocket 14 made of two sheets of syntheticmaterial welded together by their edges. Pocket 14 contains a filter 17and injection means consisting, more particularly, of a tube 23comprising an injection needle 15 protected by a cap 16.

Filter 17, seen in FIG. 2, consists of a piece of fabric in the form ofa sleeve, one end thereof being held by the weld at the bottom of thepocket, while the other end accommodates a ferrule 18 to which it isattached by the weld joining together the two sheets of which the pocketis made.

In one particular configurationof the invention, ferrule 18 has aninternal wall 19 intended to be pierced by a hollow needle 20 integralwith a sleeve 21 connected to the injection needle by means of a tube23.

A description will now be given of the method of using the deviceillustrated in FIGS. 1 and 2. Hollow needle 4 is inserted into thepatients vein. After the blood has been collected in pocket 1, tube 3 isflattened in the vicinity of the pocket and its walls are weldedtogether in order to close it off. The remainder of the tube, which isno longer in use, is then cut off.

such as cryo-precipitation, in order to separate an element"(such asfactor VIII) used against haemophilia. After tube 8 has been closed off,the element of the blood to be separated is decanted, through tubes 11and '12, into pocket which contains an isotonic solution to be mixedwith the element. This mixture is then transferred to pocket 14 throughtube 13.

Another way of using the present device consistsin passing the plasmacontained in pocket 1 through tubes 8 and 12 into pocket 10, tube 11being closed off, for example by means of a clamp. The componentcontained in the plasma (more particularly factor VIII which is usedagainst haemophilia) is separated by cryo-precipitation in pocket 10.The unprecipitated fraction of the plasma is transferred to pocket 6through tubes 11 and 12, after tube 8 has been closed off, for examplewith a clamp. The isotonic solution, which in this configuration of theinvention, is contained in storage pocket 14, is transferred to pocket10 where it is used to dilute the component separated bycryo-precipitation. Pocket 10 is carefully rinsed with this solution,and the mixture of isotonic solution and component is transferred topocket 14 through tube 13.

Tube 13 is then flattened and welded and pocket 14 is then separatedfrom pocket 10 by cutting the tube. The blood elements in pockets 1 and6 are then retained for specific purposes, while the component in pocket14 may be kept therein until it is-required for use.

At the time of use, sleeve 21 is pushed into ferrule 18 in a manner suchthat needle 20 pierces wall 19, after which needle 15 is inserted intothe patients veinand the component in its isotonic solution is injecteddirectly by rolling up pocket 14 in order to force the liquid throughtube 23. The agglomerated elements cannot pass through filter 17 andthey therefore remain in pocket 14. Dead volumes are limited to aminimum since pocket 14 is small in size and the useful volume thereofcorresponds substantially to the volume of component placed in solutionfor injection into the patient; moreover, the filtermeans is integratedinto the storage pocket. A device of this kind also preventscontamination and ensures storage and injection under completely sterileconditions.

FIG. 3 shows blood-taking pocket 1 with its means for taking blood,namely hollow needle 4 protected by cap 5. This pocket is connected,through tube 32, to a second pocket 30 which is connected in turn,through a tube 33, to a third pocket 31 and, through a tube 34, to astorage pocket 14. This latter pocket comprises a filter 17 integralwith a ferrule 18 as described in connection with FIG. 2, the ferrulebeing integral with a sterile access port 35, and the end of the ferrulebeing adaptable to the injection means.

The method of using this device to isolate and inject a componentcontaining agglomerated elements will now be described.

The blood taken from the subjects vein is subjected to initialfractionation in pocket 1, more particularly by .centrifuging. Theplasma is transferred, through tube 32, to pocket 30, after which thetube is heat sealed or welded and cut off. The plasma in pocket 30 isagain fractionated, more particularly by cryo-precipitation, in order toisolate those components which are present in very small quantities inhuman blood and which possess therapeutical properties. After beingthawed out, the liquid fraction of the plasma is transferred, throughtube 33, to pocket 31, during which transfer tube 34 is closed off, forexample with a clamp. After tube 32 has been closed off, the rinsingsolution in storage pocket 14 ispassed, through tube 34, into pocket 30which contains the component separated by cryoprecipitation. The mixturethus obtained is again transferred to pocket 14, where it is retainedafter tube 34 has been welded and cut off. During this latter operation,sterile air trapped in pocket 14 is evacuated through tube 34, so thatpocket 14 is completely filled. In order to inject the solutioncontaining the component into the patients vein, a catheter containing atube of very small cross section is connected to pocket 14. Thiscatheter is fitted to ferrule 18 in access port 35 after the port hasbeen opened under sterile conditions. The liquid is then injected bycompressing pocket 14. The agglomerated elements are retained in pocket14 by filter 17. Moreover, there is no risk of introducing air into thepatients vein, since care is taken to remove the air from pocket 14before it is sealed. Moreover, the dead volume of the injection tube isas small as possible, and almost the entire amount of the solutioncontained in the storage pocket is injected. Finally, the injectionmeans may be disconnected from access port 35 in pocket 14 and connectedto a new pocket. It is thus possible to inject into the patients vein asmany doses as may be required, with no fear of the fine injection tubebecoming blocked.

It is to be understood thatthe invention is not restricted ininterpretation except by the scope of the following claims.

I claim:

1. In an apparatus for sampling and fractionating blood componentsincluding a plurality of sampling and fractionating pocketsinterconnected by tubing, a means for sequentially isolating, storingand intravenously injecting into a patient a blood component present insmall amounts in the blood and liable to contain agglomerated elements,

said means comprising:

a distinct storage pocket for said component,

the inlet of said storage pocket being connected by sectionable tubingto said plurality of sampling and fractionating pockets, the outlet ofsaid storage pocket being sealed and having means for being equippedwith injection means; I a filter means for'preventing the injection ofthe agglomerated elements incorporated inside said storage pocketbetween said inlet and said outlet; said storage pocket being ofdimensions substantially corresponding to the quantity of the componentseparated.

2. An apparatus according to claim 1, wherin said filter means consistsof a tubular length of a filter fabric in the form of a sleeve runninglongitudinally inside said storage pocket,

one end of said sleeve being held closed at the bottom of said storagepocket,

the other end surrounding an outlet ferrule, said other end and saidferrule being held at the top of said storage pocket. J

other end and said ferrule being held between said sheets by the weld atthe top of said storage pocket.

4. An apparatus according to claim 2, wherein said injection means isintegral with said outlet ferrule.

5. An apparatus according to claim 2, wherein said outlet ferrule isfurther surrounded by a sterile access port, said injection means beingadaptable to said access port.

1. In an apparatus for sampling and fractionating blood componentsincluding a plurality of sampling and fractionating pocketsinterconnected by tubing, a means for sequentially isolating, storingand intravenously injecting into a patient a blood component present insmall amounts in the blood and liable to contain agglomerated elements,said means comprising: a distinct storage pocket for said component, theinlet of said storage pocket being connected by sectionable tubing tosaid plurality of sampling and fractionating pockets, the outlet of saidstorage pocket being sealed and having means for being equipped withinjection means; a filter means for preventing the injection of theagglomerated elements incorporated inside said storage pocket betweensaid inlet and said outlet; said storage pocket being of dimensionssubstantially corresponding to the quantity of the componentseparated.
 1. In an apparatus for sampling and fractionating bloodcomponents including a plurality of sampling and fractionating pocketsinterconnected by tubing, a means for sequentially isolating, storingand intravenously injecting into a patient a blood component present insmall amounts in the blood and liable to contain agglomerated elements,said means comprising: a distinct storage pocket for said component, theinlet of said storage pocket being connected by sectionable tubing tosaid plurality of sampling and fractionating pockets, the outlet of saidstorage pocket being sealed and having means for being equipped withinjection means; a filter means for preventing the injection of theagglomerated elements incorporated inside said storage pocket betweensaid inlet and said outlet; said storage pocket being of dimensionssubstantially corresponding to the quantity of the component separated.2. An apparatus according to claim 1, wherin said filter means consistsof a tubular length of a filter fabric in the form of a sleeve runninglongitudinally inside said storage pocket, one end of said sleeve beingheld closed at the bottom of said storage pocket, the other endsurrounding an outlet ferrule, said other end and said ferrule beingheld at the top of said storage pocket.
 3. An apparatus according toclaim 1, wherein said storage pocket is composed of two sheets havingsides welded together; said filter means consisting of a tubular lengthof a filter fabric in the form of a sleeve running longitudinally insidesaid storage pocket, one end of said sleeve being held closed betweensaid sheets by the weld at the bottom of said storage pocket, the otherend surrounding an outlet ferrule, said other end and said ferrule beingheld between said sheets by the weld at the top of said storage pocket.4. An apparatus according to claim 2, wherein said injection means isintegral with said outlet ferrule.